USDM Life Sciences

09/04/2026

Are you EUDAMED-ready — or just EUDAMED-aware?

Jay Crowley shares 4 questions medical device manufacturers should be asking right now:
✅ Do we have a validated, governed source of truth for UDI data?
✅ Do we know which devices register now vs. later?
✅ Do we understand how device/label changes trigger new obligations?
✅ Can our tools and teams handle ongoing maintenance, not just the first submission?

If you're not sure, it's time to treat readiness as a program, not a filing exercise.

Read more:

Blog post: Learn how to improve EU MDR/IVDR EUDAMED readiness with practical steps for data, registration, governance, and global medical device regulatory alignment.

09/04/2026

We're hiring: Senior Sales Executive (MidAtlantic/Northeast)

Join USDM Life Sciences and help biotech, pharma, and medical device companies navigate GxP technology and AI-enabled transformation. Own a named territory, build C-suite relationships, and drive real growth in a fast-moving industry.

📍 MidAtlantic/Northeast | 💰 OTE $231K–$346.6K | 🏠 Remote

Apply now →

Apply for Senior Sales Executive at USDM Life Sciences in United States. Full-time Mid-Senior level role. See responsibilities, qualifications, and similar jobs on LinkedIn.

09/04/2026

USDM is on the road this fall. Catch us at RAPS Convergence, The Blue Mountain Summit, and Veeva R&D and Quality Summit — talking AI governance, UDI compliance, GMP asset management, and connected life sciences operations. See more:

The only partner that governs AI AND builds it within GxP guardrails.

09/03/2026

Life sciences companies lose hundreds of hours every year validating IT workflows for FDA compliance — most of it in spreadsheets.
ProcessX is a pre-validated GxP platform on ServiceNow. Part 11 e-signatures, ALCOA Plus audit trails, validated change control. Ready in 6-12 weeks. 75% cycle time reduction.
Developed by USDM Life Sciences. Trusted by 900+ life sciences companies globally.
See it in action → https://processx.com/servicenow-for-life-sciences

09/03/2026

Join USDM at RAPS Convergence 2026 (Sept 15–17, Charlotte, NC) for a Lunch & Learn on managing global UDI compliance, plus two speaking sessions on EUDAMED, RIM implications, and sustained UDI operating models. The EUDAMED clock is ticking — device registration and UDI submissions are due Nov 27, 2026.

Learn more:

Meet USDM at RAPS Convergence 2026 and hear USDM's Jay Crowley speak on managing global UDI compliance ahead of EUDAMED implementation.

09/03/2026

Fast answers aren't enough in regulated life sciences. They need to be permission-aware, citable, and audit-ready.

That's where USDM + Glean come in. We pair Glean's Work AI platform with GxP validation, governed connectors, and life sciences-specific agents — turning enterprise search into something quality, regulatory, and manufacturing teams can actually trust.

From inspection readiness to SOP analysis to deviation support, we help teams move from search to governed agents without losing human accountability.

Explore the partnership:

Glean Work AI paired with USDM GxP validation, governance, connectors, agents, inspection readiness, and adoption services for regulated life sciences teams.

09/02/2026

Boston Scientific. Stryker. West Pharma. Medtronic. Novo Nordisk. iRhythm. Amgen.

Seven major life sciences cyber incidents in 2026 alone — and they didn't all break the same way. Some hit data. Some hit manufacturing and shipping. Some hit both.

USDM breaks down the 4 patterns emerging across this year's disclosures, and why cyber resilience has to be treated as business resilience, not just an IT problem.

Blog post: Boston Scientific's 2026 cyber incident shows why life sciences cyber risk must be evaluated through data exposure, operational disruption, third-party dependencies, and enterprise resilience.

09/02/2026

USDM is heading to The Blue Mountain Summit 2026 (Sept 15–17, Durham, NC) 🔧

If your team runs Blue Mountain RAM, let's talk GMP asset management, calibration governance, EAM/CMMS integrations, and connected operations that hold up to inspection. Meet us there:

Meet USDM at The Blue Mountain Summit 2026 in Durham, North Carolina to discuss GMP asset management, calibration, maintenance, system integrations, EAM/CMMS strategy, and connected operations for life sciences.

09/01/2026

Our AI pilot looked great. Will it survive scale?

Token costs can grow faster than they fall. Regulators want inspection-ready evidence. And governance-first isn't a brake on AI — it's what makes it defensible.

Our new white paper, The CxO Guide to Sustainable AI, gives CEOs, CIOs, CTOs, and Compliance leaders a 90-day framework for governance, validation, cost resilience, and AI literacy in regulated life sciences.

Download it:

White paper: Governance, Validation, Architecture, and Cost Resilience in Regulated Life Sciences - a strategic framework for CEOs, CIOs, CTOs, CCOs, and VP Regulatory Affairs.

09/01/2026

If your CRO gets hit by ransomware, that's your problem — not theirs.

Under ICH E6(R3), sponsors are accountable for every third party in their ecosystem, including CRO subcontractors. No exceptions.

Our Head of Cybersecurity Services breaks down the three-tier vendor model, real-world breaches (JP Morgan, DM Clinical Research, Change Healthcare), and what a real third-party risk program looks like.

Watch the highlight ↓
https://youtu.be/gkEptq-jKcQ

Under ICH E6(R3), if your CRO gets hit by ransomware — that's your ...